98 results · 14ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

FDA Recall
Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code POE·July 6, 2023

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

FDA Recall
Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQL·July 6, 2023

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

FDA Recall
Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·March 27, 2025

Pentacam HR REF 70900. Used to image the anterior segment of the eye.

FDA Recall
Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

FDA Recall
Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

FDA Recall
Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

FDA Recall
Open, Classified ·AMO Puerto Rico Manufacturing, Inc. Rd #·Product code HQL·February 19, 2026

TECNIS Toric II OptiBlue IOL Models ZCW

FDA Recall
Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code MJP·December 12, 2023

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

FDA Recall
Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code MFK·March 27, 2025

RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

FDA Recall
Open, Classified ·Rayner Intraocular Lenses Ltd 10 Dominion Way Worthing United Kingdom·Product code HQL·May 13, 2022

Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

FDA Recall
Open, Classified ·Vortex Surgical Inc.·Product code HMQ·December 16, 2025

Akreos, SKU: AO60P0300. Akreos intraocular lenses

FDA Recall
Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·June 6, 2025

FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·August 31, 2022

FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·August 31, 2022

TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·August 31, 2022

FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·August 31, 2022

FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·August 31, 2022

TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

FDA Recall
Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023